Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Colonic Polyps

Polyps

Adenomatous Polyps

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Polyps

In the GGC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure, except that at some point prior to commencing withdrawal of the colonoscope, a member of the endoscopy staff will turn on the GI Genius machine. This will remain operational from the time it is switched on until the end of the procedure.

In the SC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure.

Participants will undergo diagnostic colonoscopy, which will be identical to the normal standard of care at the unit where they are undergoing their procedure, except that GI Genius will be turned on during the procedure.

GI Genius-assisted diagnostic colonoscopy

Diagnostic colonoscopy will be performed as per the standard of care for the unit where the patient is having their procedure.

Diagnostic Colonoscopy

Colin J Rees, MBBS

COLO-DETECT is a clinical trial to evaluate whether an Artificial Intelligence device ("GI Genius", manufactured by Medtronic) can identify more polyps (pre-cancerous growths of the bowel lining) during colonoscopy (large bowel camera test) than during colonoscopy without it.

Colorectal cancer is common, affecting 1 in 15 men and 1 in 18 women in the UK in their lifetime. Many colorectal cancers develop from polyps via the adenoma-carcinoma sequence: there is a pre-cancerous stage (adenoma) during which it is possible to remove the polyp and therefore prevent it from progressing to colorectal cancer. The gold standard tool for doing this is colonoscopy. However, colonoscopy does not pick up all polyps, particularly flat polyps.

Missed polyps can result in colorectal cancer, so it is imperative to detect and remove as many polyps as possible. Many different interventions have been introduced to improve polyp detection, the most recent of which is artificial intelligence devices. GI Genius is an artificial intelligence device which integrates with existing colonoscopy equipment and analyses the video feed from the colonoscope camera in real time. Any areas that may represent an abnormality are then highlighted (without any lag) within a green box, alerting the colonoscopist to its presence. The potential abnormality can then be assessed more closely by the colonoscopist to decide whether it needs to be removed or not.

COLO-DETECT is a 2-arm, prospective, randomised controlled trial to assess whether GI Genius is able to detect more polyps (specifically, adenomas) during colonoscopy than standard colonoscopy without GI Genius. The primary outcome will be the mean number of adenomas per procedure (MAP) and the key secondary outcome will be the proportion of colonoscopies in which one or more adenomas is detected (Adenoma Detection Rate - ADR). These are both important quality markers for colonoscopy; the study will be powered to detect a clinically meaningful difference in ADR, which will by default detect a meaningful difference in MAP as the sample size required for ADR is larger.

In addition to measuring the effect of GI Genius on polyp detection, COLO-DETECT will provide a health economics analysis concerning the use of GI Genius, perform long-term passive follow-up to examine for future outcomes related to colorectal polyps and colorectal cancer, and perform additional nested studies (subject to ethical approval) that examine the effect upon users (for example through a visual scanning study) and their experience of using the GI Genius.

The patient and colonoscopist (care provider) cannot be blinded to the allocation. The investigator and statistician will remain blinded to the allocation until analysis has been conducted.

COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?

COLO-DETECT: A Randomised Controlled Trial of Lesion Detection at Colonoscopy Using the GI Genius Artificial Intelligence Platform

Equipment, staff, histology, unplanned admission, and other related costs will be calculated and used to determine cost-effectiveness of GGC versus SC.

MAP values over the duration of the study, for colonoscopists not participating in the study but performing colonoscopy at study sites, will assist with baseline comparisons. These data are reported by endoscopy units as part of the normal endoscopy quality assurance programme.

ADR values over the duration of the study, for colonoscopists not participating in the study but performing colonoscopy at study sites, will assist with baseline comparisons. These data are reported by endoscopy units as part of the normal endoscopy quality assurance programme.

The number of adenomas identified during each colonoscopy will be summed and divided by the total number of colonoscopies performed. MAP is usually expressed as a number to one decimal place (e.g. 1.2).

Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies to give the ADR. ADR is usually expressed as a percentage.

The number of adenomas identified during each colonoscopy within the 'screening' participant population will be summed and divided by the total number of colonoscopies in that participant population. The MAP for the 'screening' participant population within each study arm will be compared

The number of adenomas identified during each colonoscopy within the 'symptomatic' participant population will be summed and divided by the total number of colonoscopies in that participant population to calculate MAP. The MAP for the 'symptomatic' participant population within each study arm will be compared

Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant within the 'screening' participant population. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies in that participant population to calculate ADR. The ADR for the 'screening' participant population within each study arm will be compared

Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant within the 'symptomatic' participant population. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies in that participant population to calculate ADR. The ADR for the 'symptomatic' participant population within each study arm will be compared

The total number of polyps detected during each colonoscopy will be summed, and divided by the total number of colonoscopies, to calculate MPP. MPP is usually expressed as a number to one decimal place.

The total number of polyps detected during colonoscopy for each participant within the 'screening' participant population. will be summed, and divided by the total number of colonoscopies in that participant population, to calculate MPP. MPP is usually expressed as a number to one decimal place.

The total number of polyps detected during colonoscopy for each participant within the 'symptomatic' participant population will be summed, and divided by the total number of colonoscopies in that participant population, to calculate MPP. MPP is usually expressed as a number to one decimal place.

Whether or not at least one polyp is detected at colonoscopy will be determined for each participant. The number of colonoscopies where one or more polyps is detected will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.

Whether or not at least one polyp is detected at colonoscopy will be determined for each participant within the 'screening' participant population. The number of colonoscopies where one or more polyps is identified will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.

Whether or not at least one polyp is detected at colonoscopy will be determined for each participant within the 'symptomatic' participant population. The number of colonoscopies where one or more polyps is identified will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.

The location, size, and morphology of the polyps identified (and histology if retrieved) in each study arm will be compared. This will also be analysed for both the screening and symptomatic participant populations in each study arm.

The number of colonoscopies in each study arm in which one or more SSPs is identified, divided by the total number of colonoscopies in each arm. This will also be analysed for both the screening and symptomatic participant populations in each study arm.

The number of CRCs detected in each study arm divided by the total number of colonoscopies in each arm. This will include polyps removed and later found to cancerous on histology and lesions felt to be cancerous at the time of colonoscopy. This will also be analysed for both the screening and symptomatic participant populations in each study arm.

The number of AAs detected in each study arm divided by the total number of colonoscopies in each arm. This will also be analysed for both the screening and symptomatic participant populations in each study arm.

Caecal intubation rate (the proportion of colonoscopies in which the colonoscope reaches the furthest extent of the colon) will be compared between the study arms to assess for non-inferiority

Insertion time to caecum (time taken to reach the furthest point of the large bowel) will be compared between the study arms to assess for non-inferiority

Total time required to perform the colonoscopy will be compared between the study arms to assess for non-inferiority

Total withdrawal time (time taken to remove the colonoscope from the furthest point of the colon) in the absence of any polyps will be compared between the study arms to assess for non-inferiority

Colonoscopist-assessed patient comfort scores will be compared between the study arms to assess for non-inferiority

Nurse-assessed patient comfort scores will be compared between the study arms to assess for non-inferiority

A validated Patient-Reported Experience Measure (Newcastle ENDOPREM) will be used to compare patient experience of colonoscopy between study arms

The EuroQoL EQ-5D-5L (validated quality of life questionnaire) will be used to compare patient-reported health-related quality of life, between study arms

The need for further colonoscopy for each participant is determined by the findings at the index colonoscopy, according to national guidelines on polyp surveillance. This may differ between study arms if more polyps are identified in one arm.

Some colonoscopists partake in the national Bowel Cancer Screening Programme (BCSP) and some do not. MAP will be analysed by colonoscopist status within each study arm.

Some colonoscopists partake in the national Bowel Cancer Screening Programme (BCSP) and some do not. ADR will be analysed by colonoscopist status within each study arm.

MAP for the first 20 percent of participants will be compared to MAP for the last 20 percent of participants scoped by each participating colonoscopist, to assess for change over the course of the study.

ADR for the first 20 percent of participants will be compared to ADR for the last 20 percent of participants scoped by each participating colonoscopist, to assess for change over the course of the study.

MAP may vary from baseline, even in the control arm due to a contamination or learning effect; comparing baseline values to those during the study assesses for this effect.

ADR may vary from baseline, even in the control arm due to a contamination or learning effect; comparing baseline values to those during the study assesses for this effect.

North Wales Organisation for Randomised Trials in Health

Newcastle University

Medtronic

South Tyneside and Sunderland NHS Foundation Trust

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Treatment of rectal lesions with UNI-VEC

Ariadna Camps, Biomedical engineering

Carlos Álvarez, Medicine

Salvadora Delgado, Medicine

José F Noguera, Medicin

José F Noguera, Medicine

Alba Gómez, Medicine

Olga Maseda, Medicine

Raquel Sánchez, Medicine

Marta Jiménez, Medicine

Mario Álvarez, Medicine

Pedro Parra, Medicine

Javier Sánchez, Medicine

Blas Flor, Medicine

The aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named UNI-VEC) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). This is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial).

Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device

The device must allow the removal of polyps with a minimum size of 2 cm (maximum diameter of the removed polyp measured in mm) in the rectum.

Anorectal hemorrhagic events for each patinet will be recorded in a table and the number of events will be counted.

The number of injuries to the anorectal canal and perianal region will be recoreded in a table and then the total number of injuries will be counted.

Anorectal continence will be assesed for each Participant with the Wexner Score

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?	NCT04723758	Colonic Polyp Colorectal Poly... Colorectal Aden... Colorectal Aden... Colorectal SSA Sessile Serrate... Sessile Colonic...	GI Genius-assis... Diagnostic Colo...	18 Years -	South Tyneside and Sunderland NHS Foundation Trust
COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?	NCT04723758	Colonic Polyp Colorectal Poly... Colorectal Aden... Colorectal Aden... Colorectal SSA Sessile Serrate... Sessile Colonic...	GI Genius-assis... Diagnostic Colo...	18 Years -	South Tyneside and Sunderland NHS Foundation Trust
Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device	NCT06286956	Rectal Polyp Rectal Polyps Rectal Lesion Sessile Colonic... Pedunculated Co...	Treatment of re...	18 Years -	Vecmedical Spain, S.L.
COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?	NCT04723758	Colonic Polyp Colorectal Poly... Colorectal Aden... Colorectal Aden... Colorectal SSA Sessile Serrate... Sessile Colonic...	GI Genius-assis... Diagnostic Colo...	18 Years -	South Tyneside and Sunderland NHS Foundation Trust

Spots Global Cancer Trial Database for sessile colonic polyp